FDA Issues Draft Guidance for Radio Frequency Wireless Technology in Medical Devices

January 29, 2007 FDA Issues Draft Guidance for Radio Frequency Wireless Technology in Medical Devices On January 3, 2007, the U.S. Food and Drug Administration (FDA) issued draft guidance for issues and concerns about the safe and effective use of radio frequency wireless technology in medical devices. The issues addressed include: wireless coexistence, performance, data integrity, security, and electromagnetic compatibility. The FDA encourages device manufacturers to consider these issues at all stages of product lifecycles. Special attention should be paid in the pre-market phase to identification, documentation, and implementation of product design requirements; design verification and validation; and . . .